Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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01 1Chunghwa Chemical Synthesis & Biotech
02 1TAPI Technology & API Services
03 1Ash Stevens
04 1Fujian South Pharmaceutical
05 1Hangzhou Longshine Bio-Tech
06 1Hetero Drugs
07 1Hunan Huateng Pharmaceutical Co ltd
08 2MSN Laboratories
09 1Natco Pharma
10 1Saintsun Pharma
11 1Sichuan Huiyu Pharmaceutical
12 1Sichuan Qingmu Pharmaceutical
13 1Sun Pharmaceutical Industries Limited
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01 6China
02 5India
03 1Israel
04 1Taiwan
05 1U.S.A
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01 2Active
02 12Blank
01 14Blank
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01 14Blank
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01 1WC-0349
02 1WC-0349A9
03 12Blank
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01 120190308-211-J-316
02 13Blank
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01 148957-0056
02 152076-6224
03 154893-0084
04 11Blank
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6224
Start Marketing Date : 2017-01-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-05
Pay. Date : 2019-09-12
DMF Number : 34048
Submission : 2019-09-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33533
Submission : 2019-01-31
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0084
Start Marketing Date : 2019-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-09-30
Valid Till : 2022-05-05
Written Confirmation Number : WC-0349A9
Address of the Firm :
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A Ninlaro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ninlaro, including repackagers and relabelers. The FDA regulates Ninlaro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ninlaro API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ninlaro supplier is an individual or a company that provides Ninlaro active pharmaceutical ingredient (API) or Ninlaro finished formulations upon request. The Ninlaro suppliers may include Ninlaro API manufacturers, exporters, distributors and traders.
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